A Randomized Controlled Multicenter US Food and Drug Administration Trial of the Safety and Efficacy of the Minerva Endometrial Ablation System: One-Year Follow-Up Results.

Study Objective: To assess the safety and effectiveness of the Minerva Endometrial Ablation System for the treatment of heavy menstrual bleeding in premenopausal women.

Design: Multicenter, randomized, controlled, international study (Canadian Task Force classification I).

Setting: Thirteen academic and private medical centers.